To evaluate the effect of Shunaoxin Dropping Pills on objective sleep parameters and inflammatory markers in patients with cerebral small vessel disease (CSVD).

One hundred and four patients with CSVD from Neurology Department of Tianjin Medical University General Hospital and Neurosurgery Department of Tianjin Hospital of ITCWN were collected from June 2020 to September 2022. They were randomly divided into two groups according to the random number table: the control group which received normalization therapy and the Shunaoxin treatment group which received Shunaoxin Dropping Pills and normalization therapy. The objective sleep parameters were evaluated by the portable sleep monitor. The plasma levels of C-reactive protein (CRP), interleukin-6 (IL-6), soluble P-selectin, soluble vascular cell adhesion molecule-1 (sVCAM-1), intercellular adhesion molecule-1 (ICAM-1) were measured by enzyme linked immunosorbent assay. The above evaluations were performed at baseline and after therapy of 3 months.

As 1 patient dropped out, there were 54 available cases in the control group. As 2 patients dropped out, there were 47 available cases in the Shunaoxin treatment group. Compared with the control group, the Shunaoxin treatment group showed significant decreased D-value of sleep latency, increased D-value of sleep latency, and deceased D-value of plasma sVCAM-1 level after and before therapy (P<0.05); The D-values of total sleep time, rapid eye movement sleep proportion, stable sleep proportion, unstable sleep proportion, total number of awakenings, plasma CRP, IL-6, soluble P-selectin, and plasma ICAM-1 levels before and after treatment were not statistically significant (P>0.05). The changes of sleep efficiency were negatively correlated with the changes of plasma level of sVCAM-1 (r=-0.419, P=0.003) in the Shunaoxin treatment group.

Based on the normalization therapy with antiplatelet and lipid-regulating therapy, and treatment of cerebrovascular risk factors, therapy with Shunaoxin Dropping Pills for 3 months can decrease sleep latency and improve sleep efficiency, as well as alleviate the inflammation of vascular endothelium in the patients with CSVD. In addition, the increase of sleep efficiency was correlated with the decrease of vascular inflammation in the patients with CSVD.